Apparatus and method for concurrently forming a gastroesophageal valve and tightening the lower esophageal sphincter

ABSTRACT

An apparatus enables concurrent restoration of a gastroesophageal valve and tightening of the lower esophageal sphincter. The apparatus comprises a longitudinal member having a distal end arranged to be received within a stomach, a tissue shaper at the distal end of the longitudinal member that forms a gastroesophageal valve from stomach tissue, and a tissue gatherer that gathers fundus tissue at or aboral to the gastroesophageal junction to reduce an esophageal opening into the stomach and tighten the lower esophageal sphincter. A fastener deployer then deploys at least one fastener pair to maintain both the restored gastroesophageal valve and the tightened lower esophageal sphincter.

RELATED APPLICATION DATA

This application is a division of U.S. application Ser. No. 14/886,850filed Oct. 19, 2015, which is a division of U.S. application Ser. No.13/716,061 filed Dec. 14, 2012, now U.S. Pat. No. 9,161,754 issued Oct.20, 2015, which is a continuation of U.S. application Ser. No.12/870,815 filed Aug. 28, 2010, now abandoned, which is a continuationof Ser. No. 12/319,228 filed Jan. 2, 2009, now abandoned, which is acontinuation of Ser. No. 11/291,500 filed Dec. 1, 2005, now abandoned.

FIELD OF THE INVENTION

The present invention generally relates to manipulation of stomachtissue as by folding or molding and stomach tissue fixation to treatgastroesophageal reflux disease. The present invention more particularlyrelates to the restoration of a gastroesophageal valve and theconcurrent tightening of the lower esophageal sphincter.

BACKGROUND

Gastroesophageal reflux disease (GERD) is a chronic condition caused bythe failure of the anti-reflux barrier located at the gastroesophagealjunction to keep the contents of the stomach from splashing into theesophagus. The splashing is known as gastroesophageal reflux. Thestomach acid is designed to digest meat, and will digest esophagealtissue when persistently splashed into the esophagus.

A principal reason for regurgitation associated with GERD is themechanical failure of a deteriorated gastroesophageal valve to close andseal against pressure in the stomach. Due to reasons includinglifestyle, a Grade I normal gastroesophageal valve may deteriorate intoa malfunctioning Grade III or absent gastroesophageal valve Grade IV.With a deteriorated gastroesophageal valve, the stomach contents aremore likely to be regurgitated into the esophagus, the mouth, and eventhe lungs. The regurgitation is referred to as “heartburn” because themost common symptom is a burning discomfort in the chest under thebreastbone. Burning discomfort in the chest and regurgitation ofsour-tasting gastric juice into the mouth are classic symptoms ofgastroesophageal reflux disease (GERD). When stomach acid isregurgitated into the esophagus, it is usually cleared quickly byesophageal contractions and esophageal clearance as a result fromswallowing. Heartburn as a result from backwashing of stomach acid andbile onto the esophagus results when stomach acid is frequentlyregurgitated into the esophagus and the esophageal wall is inflamed.

Complications develop for some people who have GERD. Esophagitis(inflammation of the esophagus) with erosions and ulcerations (breaks inthe lining of the esophagus) can occur from repeated and prolonged acidexposure. If these breaks are deep, bleeding or scarring of theesophagus with formation of a stricture (narrowing of the esophagus) canoccur. If the esophagus narrows significantly, then food sticks in theesophagus and the symptom is known as dysphagia. GERD has been shown tobe one of the most important risk factors for the development ofesophageal adenocarcinoma. In a subset of people who have severe GERD,if acid exposure continues, the injured squamous lining is replaced by aprecancerous lining called Barrett's Esophagus in which a cancerousesophageal adenocarcinoma can develop.

Other complications of GERD may not appear to be related to esophagealdisease at all. Some people with GERD may develop recurrent pneumonia(lung infection), asthma (wheezing), or a chronic cough from acidbacking up into the esophagus and all the way up through the upperesophageal sphincter into the lungs. In many instances, this occurs atnight, while the person is in a supine position and sleeping.Occasionally, a person with severe GERD will be awakened from sleep witha choking sensation. Hoarseness can also occur due to acid reaching thevocal cords, causing a chronic inflammation or injury.

GERD never improves without intervention. Life style changes combinedwith both medical and surgical treatments exist for GERD. Medicaltherapies include antacids; antisecretory drugs such as H2-blockers, andproton pump inhibitors. However, the medical therapies only mask thereflux. Patients still get reflux, asthma, and perhaps even emphysemabecause of gastric contents and particles refluxed into the lungs.Barrett's esophagus results in about 10% of the GERD cases. Theesophageal epithelium changes into intestinal metaplastic epitheliumtissue that tends to become cancerous from repeated acid washing despitethe medication.

Several open laparotomy and laparoscopic surgical procedures areavailable for treating GERD. One surgical approach is the Nissenfundoplication. The Nissen approach typically involves a 360-degree wrapof the fundus around the gastroesophageal junction. The procedure has ahigh incidence of postoperative complications. The Nissen approachcreates a 360-degree moveable valve, typically without a fixed portion.Hence, Nissen does not restore the normal movable flap of the valve. Thepatient's frequency cannot burp because the fundus was used to make therepair by wrapping it around the esophagus, and may experiencedysphagia. Another surgical approach to treating GERD is the Belsey MarkIV (Belsey) fundoplication. The Belsey procedure involves creating avalve by suturing a portion of the stomach to an anterior surface of theesophagus. It reduces some of the postoperative complicationsencountered with the Nissen fundoplication, but still does not restorean anatomical normal movable flap. None of these procedures fullyrestores the normal anatomical anatomy or produces a normallyfunctioning gastroesophageal junction. Another surgical approach is theHill repair. In the Hill repair, the gastroesophageal junction isanchored to the posterior abdominal areas, and a 180-270 degree valve iscreated by a system of sutures. The Hill procedure restores the moveableflap, the cardiac notch and the Angle of His. However, all of thesesurgical procedures are very invasive, regardless of whether done as alaparoscopic or an open procedure.

New, less surgically invasive approaches to treating GERD involvetransoral endoscopic procedures. One procedure contemplates a machinedevice with robotic arms that is inserted transorally into the stomach.While observing through an endoscope, an endoscopist guides the machinewithin the stomach to engage a portion of the fundus with acorkscrew-like device on one arm. The arm then pulls on the engagedportion to create a fold of tissue or radial plication at thegastroesophageal junction. Another arm of the machine pinches the excesstissue together and fastens the excess tissue with one pre-tied implant.This procedure does not restore normal anatomy. The fold created doesnot have anything in common with a valve. In fact, the direction of theradial fold prevents the fold or plication from acting as a flap of avalve.

Another transoral procedure contemplates making a fold of fundus tissuenear the deteriorated gastroesophageal flap to recreate the loweresophageal sphincter (LES). The procedure requires placing multipleU-shaped tissue clips around the folded fundus to hold it in shape andin place.

This and the previously discussed procedure are both highly dependent onthe skill, experience, aggressiveness, and courage of the endoscopist.In addition, these and other procedures may involve esophageal tissue inthe repair. Esophageal tissue is fragile and weak, in part due to thefact, that the esophagus is not covered by serosa, a layer of verysturdy, yet very thin tissue, covering and stabilizing allintraabdominal organs, similar like a fascia covering and stabilizingmuscle. Involvement of esophageal tissue in the repair of agastroesophageal valve poses unnecessary risks to the patient, such asan increased risk of fistulas between the esophagus and the stomach andthe risk of mediastinitis.

A new and improved apparatus and method for restoration of agastroesophageal valve is fully disclosed in U.S. Pat. No. 6,790,214,issued Sep. 14, 2004, is assigned to the assignee of this invention, andis incorporated herein by reference. That apparatus and method providesa transoral endoscopic gastroesophageal valve restoration. Alongitudinal member arranged for transoral placement into a stomachcarries a tissue shaper that noninvasively grips and shapes stomachtissue. A tissue fixation device is then deployed to maintain the shapedstomach tissue in a shape approximating a gastroesophageal flap.

The last mentioned apparatus and method hold out great promise for theGERD sufferer. Not only are the gastroesophageal valve anatomy andfunction restored, they are restored transorally without the need forsurgical incisions. Most patients will experience a quick recovery to abetter life without GERD in a few days. Most won't even need to spend anight in the hospital.

Experience has shown that a significant percentage of patients whosuffer from GERD also have a compromised high-pressure zone and loweresophageal sphincter (LES). The compromised function of the LES isexhibited by enlargement of the perimeter of the LES and a weakenedstate of its associated muscle tissue. While a healthy lower esophagealsphincter serves as a discriminating sphincter, able to distinguishbetween burping gas, liquids, and solids, and supporting the valve toprevent reflux from happening, a compromised LES is unable to providethis function. Hence, a healthy LES provides an added protection againstGERD when working in conjunction with the gastroesophageal valve (GEV),but a compromised LES does not.

Unfortunately, none of the prior art devices or methods address theissue of restoring both the LES and the GEV during a single (concurrent)procedure. Indeed, only the last mentioned apparatus and method are evendirected to restoring the GEV. The others are solely intended to restoreLES competency. Hence, there is a need in the art to address the totalpicture for treating GERD, restoring both the LES and the GEV toeffective competency. The present invention addresses these and otherissues.

SUMMARY

The invention provides a method of treating a gastrodisorder involving apatient's stomach, esophagus, and esophageal opening into the stomach.The method comprises forming a gastroesophageal valve from stomachtissue, gathering fundus tissue at or aboral of the gastroesophagealjunction to reduce the esophageal opening, and deploying at least onefastener to maintain both the formed gastroesophageal valve and fundusfold.

The gathering step may comprise displacing the fundus tissue into theesophageal opening. The gathering step may comprise mechanicallygripping the fundus tissue. The gathering step may alternativelycomprise vacuum gathering the fundus tissue. The gathering step mayinclude gathering the fundus tissue at a gathering point. The deployingstep may comprise deploying a fastener on opposite sides of thegathering point.

The deploying step may comprise deploying at least a pair of fastenersspaced apart and the gathering step may comprise providing the fastenerswith converging trajectories during deployment.

The method may further comprise the step of placing a medical instrumentinto the stomach, and the step of forming a gastroesophageal valve maycomprise folding stomach tissue with the instrument so that serosatissue contacts serosa tissue to form a flap of stomach tissue layers.The stomach tissue layers comprise an inner tissue layer and an outertissue layer, and the gathering step may comprise gathering the innertissue and displacing the inner tissue layer into the esophageal openingwith the instrument. The gathering step may comprise mechanicallygripping the inner tissue layer or vacuum gathering the inner tissuelayer.

The gathering step may include gathering the inner tissue layer at agathering point. The deploying step may include deploying a fastenerwith the instrument through the tissue layers on opposite sides of thegathering point.

The invention further provides a method of treating a stomach disorderinvolving a patient's stomach, esophagus, and esophageal opening intothe stomach, comprising forming, in a plurality of stages, agastroesophageal valve from stomach tissue, during at least one of thestages, gathering fundus tissue at or aboral of the gastroesophagealjunction to reduce the esophageal opening and deploying at least onefastener to maintain both the formed gastroesophageal valve and reducedesophageal opening.

The gathering step may comprise gripping the fundus tissue anddisplacing the fundus tissue into the esophageal opening. The gatheringstep may again comprise mechanically gripping the fundus tissue orvacuum gathering the fundus tissue. Again, the gathering step mayinclude gathering the fundus tissue at a gathering point and thedeploying step may comprise deploying a fastener on opposite sides ofthe gathering point.

The deploying step may again comprise deploying at least a pair offasteners spaced apart and the gathering step may comprise providing thefasteners with converging trajectories during deployment.

The method may further comprise the step of placing a medical instrumentinto the stomach, and the step of forming a gastroesophageal valve maycomprise folding, during each stage, stomach tissue with the instrumentso that serosa tissue contacts serosa tissue to form a flap of stomachtissue layers. The stomach tissue layers comprise an inner tissue layerand an outer tissue layer, and the gathering step may include gatheringthe inner tissue layer and displacing the inner tissue layer into theesophageal opening with the instrument. The instrument may gather theinner tissue layer at a gathering point and deploy a fastener on eachside of the gathering point.

The instrument may be used to drive at least a pair of spaced apartfasteners from the inner tissue layer to and through the outer tissuelayer and, while driving the fasteners, providing the fasteners withdiverging drive trajectories to cause the tissue layers to be gathered.

The invention still further provides a method of restoring a patient'sgastroesophageal valve associated with the patient's stomach, esophagus,and esophageal opening into the stomach, and concurrently, tighteningthe patient's lower esophageal sphincter. The method comprises forming,from stomach tissue, a plurality of gastroesophageal valve portions in alike plurality of serially repeated stages until the gastroesophagealvalve is formed. During at least one of the stages, fundus tissue isgathered at or aboral of the gastroesophageal junction to form a fundusfold to reduce the esophageal opening. At least one fastener is thendeployed to maintain both the gastroesophageal valve portion formedduring the at least one stage and the fundus fold.

The invention further provides an apparatus arranged to treat a stomachdisorder involving a patient's stomach, esophagus, and esophagealopening into the stomach. The apparatus comprises a longitudinal memberhaving a distal end arranged to be received within a stomach, a tissueshaper at the distal end of the longitudinal member that forms agastroesophageal valve from stomach tissue, a tissue gatherer thatgathers fundus tissue at or aboral to the gastroesophageal junction toreduce the esophageal opening into the stomach, and a fastener deployerthat deploys a fastener that maintains both the gastroesophageal valveand the reduced esophageal opening.

The gatherer may be arranged to displace the fundus tissue into theesophageal opening. The gatherer may comprise a mechanical gripper thatgrips the fundus tissue. The gatherer may alternatively comprise avacuum gatherer that gathers the fundus tissue.

The gatherer may be arranged to gather the fundus tissue at a gatheringpoint and the fastener deployer may be arranged to deploy a fastener onopposite sides of the gathering point.

The fastener deployer may be arranged to deploy at least a pair offasteners spaced apart and the gatherer may be arranged to provide thefasteners with converging trajectories during deployment. The convergingtrajectories of the fasteners will cause gathering of the fundus tissueafter fastener deployment.

The tissue shaper may comprise a tissue folder that folds stomach tissuesuch that serosa tissue contacts serosa tissue to form thegastroesophageal valve from stomach tissue layers.

The stomach tissue layers comprise an inner tissue layer and an outertissue layer, and the gatherer may comprise a gatherer that gathers theinner tissue layer and displaces the inner tissue layer into theesophageal opening.

The gripper may arrange to mechanically grip the inner tissue layer. Thegripper may alternatively be arranged to vacuum gather the inner tissuelayer.

The gatherer may be arranged to gather the inner tissue layer at agathering point and the fastener deployer may be arranged to deploy afastener through the tissue layers on opposite sides of the gatheringpoint.

The tissue shaper may comprise a pair of hingedly coupled first andsecond arms. The first and second arms are arranged to receive thetissue there between and to fold the stomach tissue to form thegastroesophageal valve.

Another apparatus for treating a stomach disorder involving a patient'sstomach, esophagus, and esophageal opening into the stomach comprises atissue shaper that forms, over a plurality of stages, a gastroesophagealvalve from stomach tissue. The apparatus further comprises a tissuegatherer that folds fundus tissue at or aboral of the gastroesophagealjunction during at least one of the stages to reduce the esophagealopening and a fastener deployer that deploys at least one fastener tomaintain both the formed gastroesophageal valve and fundus fold.

According to a still further embodiment, an apparatus for restoring apatient's gastroesophageal valve associated with the patient's stomach,esophagus, and esophageal opening into the stomach, and concurrently,tightening the patient's lower esophageal sphincter comprises a tissueshaper that forms, from stomach tissue, a plurality of gastroesophagealvalve portions in a like plurality of serially repeated stages until thegastroesophageal valve is formed. The apparatus further comprises atissue gatherer that, during at least one of the stages, folds fundustissue at or aboral of the gastroesophageal junction to form a fundusfold to reduce the esophageal opening and a fastener deployer thatdeploys at least one fastener to maintain both the gastroesophagealvalve portion formed during the at least one stage and the fundus fold.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify like elements, and wherein:

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract from a lower portion of the esophagusto the duodenum;

FIG. 2 is a front cross-sectional view of theesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap of the gastroesophageal valve (in dashed lines)and a Grade III reflux appearance of the gastroesophageal valve (insolid lines);

FIG. 3 is a side view of an apparatus for restoring the flap of a GEVaccording to an embodiment of the invention;

FIG. 4 is a perspective view with portions cutaway of the apparatus ofFIG. 3 according to an embodiment of the invention illustrating internalelements at an initial stage of concurrent tightening of the LES;

FIG. 5 is a sectional view illustrating a manner in which the device ofFIGS. 3 and 4 may first grip fundus tissue for concurrently tighteningthe LES;

FIG. 6 is a sectional view showing the LES being concurrently tightenedby the device of FIGS. 3 and 4;

FIG. 7 is a perspective view with portions cutaway of the apparatus ofFIGS. 3 and 4 after deploying fasteners to maintain the concurrenttightening of the LES;

FIG. 8 is a sectional view showing the LES concurrently tightened by thedevice of FIGS. 3 and 4 after fasteners have been deployed;

FIG. 9 is a perspective view with portions cutaway of the stomach andesophagus after the LES has been concurrently tightened according to anembodiment of the invention and the device of FIGS. 3 and 4 has beenremoved;

FIG. 10 is a sectional view of the anatomy illustrated in FIG. 9;

FIG. 11 is a perspective view with portions cutaway of the stomach andesophagus after the LES has been concurrently tightened according toanother embodiment of the invention;

FIG. 12 is a sectional view of the anatomy illustrated in FIG. 11;

FIGS. 13 through 16 are sectional views illustrating incremental stepsin concurrently tightening the LES according to a further embodiment ofthe invention;

FIG. 17 is another perspective view with portions cutaway illustratingalternative internal elements of the device of FIG. 3 at an initialstage of concurrent tightening of the LES according to a still furtherembodiment of the invention;

FIG. 18 is a sectional view illustrating a manner in which the device ofFIG. 17 may first grip fundus tissue for concurrently tightening theLES;

FIG. 19 is a sectional view illustrating a manner in which the device ofFIG. 17 grips fundus tissue for concurrently tightening the LES anddeploying fasteners to maintain a tightened LES;

FIG. 20 is another perspective view with portions cutaway illustratingthe alternative internal elements of the device of FIG. 3 afterconcurrent tightening of the LES and deployment of fasteners; and

FIG. 21 is another sectional view illustrating the tightened andfastened LES resulting from use of the device of FIGS. 17 and 20.

FIG. 22 is a view showing the device and stomach after the stomach hasbeen inflated to a first pressure;

FIG. 23 is a view showing the device centered and gripping theesophagus;

FIG. 24 is a view showing the device initially gripping the stomachtissue after the stomach has been reinflated to a second, higherpressure;

FIG. 25 is a view showing the stomach partially deflated and grippedstomach tissue being pulled aborally towards the device;

FIG. 26 is a view showing the gripped stomach tissue being pulled toalmost within the device;

FIG. 27 is a view showing the gripped stomach tissue with the device,being molded, and ready to receive a fastener;

FIG. 28 is a view showing the molded stomach tissue after receiving afastener;

FIG. 29 is a perspective view illustrating a manner in which the devicemay deploy a fastener through gripped stomach tissue layers; and

FIG. 30 is a perspective view showing a fastener fully deployed.

DETAILED DESCRIPTION

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract 40 from a lower portion of theesophagus 41 to the duodenum 42. The stomach 43 is characterized by thegreater curvature 44 on the anatomical left side and the lessercurvature 45 on the anatomical right side. The tissue of the outersurfaces of those curvatures is referred to in the art as serosa tissue.As will be seen subsequently, the nature of the serosa tissue is used toadvantage for its ability to bond to like serosa tissue.

The fundus 46 of the greater curvature 44 forms the superior portion ofthe stomach 43, and traps gas and air bubbles for burping. Theesophageal tract 41 enters the stomach 43 at an esophageal orifice belowthe superior portion of the fundus 46, forming a cardiac notch 47 and anacute angle with respect to the fundus 46 known as the Angle of His 57.The lower esophageal sphincter (LES) 48 is a discriminating sphincter,which is part of the high-pressure zone of the antireflux barrier of theGEJ able to distinguish between burping gas, liquids, and solids, andworks in conjunction with the fundus 46 to burp. The gastroesophagealvalve (GEV) 49 includes a moveable portion and an opposing morestationary portion.

The moveable portion of the GEV 49 is an approximately 180 degree,semicircular, gastroesophageal flap 50 (alternatively referred to as a“normal moveable flap” or “moveable flap”) formed of tissue at theintersection between the esophagus 41 and the stomach 43. The opposingmore stationary portion of the GEV 49 comprises a portion of the lessercurvature 45 of the stomach 43 adjacent to its junction with theesophagus 41. The gastroesophageal flap 50 of the GEV 49 principallycomprises tissue adjacent to the fundus 46 portion of the stomach 43. Itis about 4 to 5 cm long (51) at it longest portion, and its length maytaper at its anterior and posterior ends.

The gastroesophageal flap 50 is partially held against the lessercurvature 45 portion of the stomach 43 by the pressure differentialbetween the stomach 43 and the thorax, and partially by the resiliencyand the anatomical structure of the GEV 49, thus providing the valvingfunction. The GEV 49 is similar to a flutter valve, with thegastroesophageal flap 50 being flexible and closeable against the othermore stationary side.

The esophageal tract is controlled by an upper esophageal sphincter(UES) in the neck near the mouth for swallowing, and by the LES 48 andthe GEV 49 at the stomach. The normal anti-reflux barrier is primarilyformed by the LES 48 and the GEV 49 acting in concert to allow food andliquid to enter the stomach, and to considerably resist reflux ofstomach contents into the esophagus 41 past the gastroesophageal tissuejunction 52. Tissue aboral of the gastroesophageal tissue junction 52 isgenerally considered part of the stomach because the tissue protectedfrom stomach acid by its own protective mechanisms. Tissue oral of thegastroesophageal junction 52 is generally considered part of theesophagus and it is not protected from injury by prolonged exposure tostomach acid. At the gastroesophageal junction 52, the juncture of thestomach and esophageal tissues form a zigzag line, which is alsoreferred to as the “Z-line.” For the purposes of these specifications,including the claims, “stomach” means the tissue aboral of thegastroesophageal junction 52.

FIG. 2 is a front cross-sectional view of anesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap 50 of the GEV 49 (shown in dashed lines) and adeteriorated Grade III gastroesophageal flap 55 of the GEV 49 (shown insolid lines). As previously mentioned, a principal reason forregurgitation associated with GERD is the mechanical failure of thedeteriorated (or reflux appearance) gastroesophageal flap 55 of the GEV49 to close and seal against the higher pressure in the stomach. Due toreasons including lifestyle, a Grade I normal gastroesophageal flap 50of the GEV 49 may deteriorate into a Grade III deterioratedgastroesophageal flap 55. The anatomical results of the deteriorationinclude moving a portion of the esophagus 41 that includes thegastroesophageal junction 52 and LES 48 toward the mouth, straighteningof the cardiac notch 47, and increasing the Angle of His 57. Thiseffectively reshapes the anatomy aboral of the gastroesophageal junction52 and forms a flattened fundus 56.

The deteriorated gastroesophageal flap 55 shown in FIG. 2 has agastroesophageal valve 49 and cardiac notch 47 that are bothsignificantly degraded. Dr. Hill and colleagues developed a gradingsystem to describe the appearance of the GEV and the likelihood that apatient will experience chronic acid reflux. L. D. Hill, et al., Thegastroesophageal valve: in vitro and in vivo observations,Gastrointestinal Endoscopy 1996: 44:541-547. Under Dr. Hill's gradingsystem, the normal movable flap 50 of the GEV 49 illustrates a Grade Ivalve that is the least likely to experience reflux. The deterioratedgastroesophageal flap 55 of the GEV 49 illustrates a Grade III (almostGrade IV) valve. Grade III and IV valves are the most likely toexperience reflux. Grades II and III reflect intermediate grades ofdeterioration and, as in the case of III, a high likelihood ofexperiencing reflux. With the deteriorated GEV represented bydeteriorated gastroesophageal flap 55 and the fundus 46 moved inferior,the stomach contents are presented a funnel-like opening directing thecontents into the esophagus 41 and the greatest likelihood ofexperiencing reflux. Disclosed subsequently are a device, assembly, andmethod, which may be employed to advantage according to an embodiment ofthe invention in restoring the normal gastroesophageal valve anatomy.

Referring now to FIG. 3, it shows a device 100 according to anembodiment of the present invention. More particularly, FIG. 3 showsthose elements of the device 100 that provide for the restoration of aGEV according to this embodiment. The elements for concurrentlytightening the LES according to various embodiments will be describedsubsequently.

The device 100 includes a longitudinal member 102 for transoralplacement of the device 100 into the stomach. The device furtherincludes a first member 104, hereinafter referred to as the chassis, anda second member 106, hereinafter referred to as the bail or mold. Thechassis 104 and bail 106 are carried at the distal end of thelongitudinal member 102 for placement in the stomach. The chassis 104and bail 106 are hingedly coupled at 107 and form a tissue shaper toshape tissue of the stomach into the flap of a restored gastroesophagealvalve.

The device 100 has a longitudinal passage 101 to permit an endoscope 110to be guided through the device and into the stomach. This permits theendoscope to service as a guide for guiding the device 100 through thepatient's throat, down the esophagus, and into the stomach. It alsopermits the gastroesophageal valve restoration procedure to be viewed ateach stage of the procedure.

As described in copending application Ser. No. 11/001,666, filed Nov.30, 2004, entitled FLEXIBLE TRANSORAL ENDOSCOPIC GASTROESOPHAGEAL VALVERESTORATION DEVICE AND METHOD, which application is incorporated hereinby reference, the device 100 is fed down the esophagus with the bail 106substantially in line with the chassis 104. To negotiate the bend of thethroat, and as described in the aforementioned referenced application,the chassis 104 and bail 106 are rendered flexible. The chassis 104 isrendered flexible by the slots 108 and the bail 106 is rendered flexibleby the hingedly coupled links 112. Further details concerning theflexibility of the chassis 104 and the bail 106 may be found in theaforementioned referenced application.

To facilitate shaping of the stomach tissue, the stomach tissue is drawnin between the chassis 104 and the bail 106. Further, to enable a flapof sufficient length to be formed to function as the flap of agastroesophageal valve, the stomach tissue is pulled down so that thefold line is substantially juxtaposed to the opening of the esophagusinto the stomach. Hence, the stomach is first gripped at a point out andaway from the esophagus and the grip point is pulled to almost thehinged connection 107 of the chassis 104 and bail 106. To this end, and,as further shown in FIG. 3, the device includes a tissue gripper 114.The gripper 114, in this embodiment, comprises a helical coil 115. Thecoil 115 is carried at the end of a cable 116 and may be attached to theend of the cable or be formed from the cable. In this embodiment, thehelical coil 115 is attached to the cable 116 and is preceded by a guide118. For a complete description of the function of the guide, togetherwith a complete description of the manner in which a GEV may be restoredwith the device if FIG. 3, reference may be had to copending U.S.application Ser. No. 11/172,427, filed Jun. 29, 2005 and incorporatedherein by reference in its entirety.

The helical coil 115 is shown in an approximate position to engage thestomach tissue out and away from the opening of the esophagus to thestomach. The helical coil 115 is guided into position by a guidestructure 120 carried on the bail 106. The guide structure 120 comprisesa guide tube 122. When the device 100 is first introduced down theesophagus into the stomach, the helical coil 115 is caused to residewell within the guide tube 122 to preclude the helical coil fromaccidentally or inadvertently snagging esophageal or stomach tissue.

The guide tube includes a longitudinal slit 126 having a circuitousconfiguration. The slit 126 permits the end of the cable to release ordisassociate from the bail after the stomach tissue is gripped. Thecircuitous configuration of the slit 126 assures confinement of thecable 116 within the guide tube 122 until release of the cable isdesired. The proximal end of the slit 126 has an enlarged portion oropening (not shown). This opening permits the cable and helical coil toreenter the lumen when the device 100 is readied for a repeated stomachtissue shaping procedure. To that end, the guide 118 has a conicalsurface that serves to guide the cable end back into the opening of theslit 126.

With continued reference to FIG. 3, the device 100 further comprises afastener deployer 140. The fastener deployer includes a plurality offastener deployment guides 142. The fastener deployment guides 142 takethe form of guide lumens. Although only one guide lumen 142 is shown, itwill be appreciated that the device 100 may include a plurality of suchlumens without departing from the invention. The guide lumen terminatesat a delivery point 144 where a fastener is driven into the moldedstomach tissue. As will be seen subsequently, the fastener deployerincludes at least two guides 142 so that fasteners may be deployed onopposite sides of a tissue gathering point to maintain both a restoredGEV and a concurrently tightened LES.

The device 100 further includes a window 130 within the chassis 104. Thewindow is formed of a transparent or semi-transparent material. Thispermits gastroesophageal anatomy, and more importantly thegastroesophageal junction (Z-line) to be viewed with the endoscope 110.The window includes a location marker 132 which has a known positionrelative to the fastener delivery point 144. Hence, by aligning themarker with a known anatomical structure, the fastener will be delivereda known distance from or at a location having a predetermined relationto the marker. For example, by aligning the marker with the Z-line, itwill be known that the fastener will be placed aboral of the Z-line andthat serosa tissue will be fastened to serosa tissue. As previouslymentioned, this has many attendant benefits.

It may also be mentioned at this point that the device 100 furtherincludes an invaginator 145 including a plurality of orifices 146. Theseorifices 146, which alternatively may be employed on the longitudinalmember 102, are used to pull a vacuum to cause the device 100 to gripthe inner surface of the esophagus. This will serve to stabilize theesophagus and maintain device positioning during the procedure. Thisvacuum gripping of the esophagus may also be used to particularadvantage if the patient suffers from a hiatal hernia. Upon being thusgripped, the esophagus may be moved downwardly with the device towardthe stomach and abdominal cavity to eliminate the hiatal hernia.

Now that a device which may be used in restoring the flap of agastroesophageal valve has been described, reference may now be made tothe various embodiments herein for the concurrent tightening of an LESalong with the restoration of a gastroesophageal valve. To the extentthat the devices to be described herein after have elements identical tothose of the device 100 of FIG. 3, like reference numerals will beemployed.

In FIG. 4, a device 200 according to one embodiment of the invention isshown. Here, it may be seen that the chassis 104 and bail 106 have beenbrought together with a formed flap of stomach tissue 43 there between.The flap of tissue includes an inner tissue layer 180 and an outertissue layer 182. Fasteners have not yet been deployed for maintainingthe fold of stomach tissue. However, as may also be seen in thecross-sectional view of FIG. 5, fastener deployment wires or stylets 202and 204 have been advanced down the guide lumens 142 to extend throughthe inner tissue layer 180 but not the outer tissue layer 182. Thisenables the inner tissue layer 180 to be mechanically gripped.

As may be further noted in FIGS. 4 and 5, the chassis 104 includes alongitudinal channel 210. The channel 210 provides a space for receivingthe inner tissue layer 180 when it displaced into the esophageal openingand thus gathered for tightening the LES.

FIG. 6 shows the inner tissue layer 180 being gathered and displacedinto the channel 210 and thus, into the esophageal opening. This isaccomplished by bringing the stylets 202 and 204 together. To this end,the longitudinal member 102 is preferably formed of a compressiblematerial. As the stylets 202 and 204 are brought towards each other, theinner tissue layer 180 is caused to fold at a gathering point 212 inbetween the stylets 202 and 204.

With the inner tissue layer 180 gathered as shown in FIG. 6, fastenersmay now be deployed to maintain both the formed flap for the restoredGEV and the gathered inner tissue layer for the tightened LES. FIGS. 7and 8 illustrate the deployed fasteners 214 and 216. The fasteners maybe deployed as described, for example, in copending U.S. applicationSer. No. 10/949,737 filed Sep. 23, 2004; Ser. No. 11/172,363 filed Jun.29, 2005; Ser. No. 11/043,903 filed Jan. 25, 2005; and Ser. No.11/172,428 filed Jun. 29, 2005 which are hereby incorporated herein intheir entireties by reference. The fasteners 214 and 216 are deployed onopposite sides of the tissue gathering point. With the fasteners 214 and216 thus deployed, the device may be rotated and the foregoing may berepeated to form another portion of the formed flap for the restoredGEV. Also, if needed, another inner tissue gathering may be carried outto provide further tightening of the LES.

FIGS. 9 and 10 show the resulting anatomy after the GEV has beenrestored, the LES has been tightened, and device has been removed. Hereit can be clearly seen that the gathered tissue inner layer 180 has beendisplaced into the esophageal opening 41 to tighten the LES and that thetissue layers 180 and 182 form a flap to in turn restore the GEV. Thebottom portion of the GEV has been cut away to permit the gathered innertissue layer tightening the LES to be clearly seen.

FIG. 11 illustrates that multiple levels of fasteners may be deployed.More specifically. In addition to fasteners 214 and 216, another pair offasteners 218 and 220 have also been deployed on opposite sides of thetissue gathering point. Also, FIG. 11 shows the entire extent of therestored GEV 49 although a middle portion has been cut away to permitall of the features of the resulting anatomy to be visible.

FIG. 12 shows a tightened LES after the inner tissue layer is gatheredfor each of three incremental rotations of the device 200. Threeseparate tissue gathering points 212 a, 212 b, and 212 c are created andmaintained by fasteners 214 a and 216 a, 214 b and 216 b, and 214 c and216 c, respectively. This creates a pleated tissue structure as shown.

FIGS. 13 through 16 illustrate another embodiment of the presentinvention. Here, the fastener guide lumens 242 cause the gathering ofthe inner tissue layer 180. More specifically, the lumens 242 arearranged to define converging trajectories of the fastener deploymentstylets 202 and 204. FIG. 13 more specifically shows the convergingstylets 202 and 204 projecting through the tissue layers 180 and 182.

FIG. 14 shows the tissue layers 180 and 182 together with the fasteners214 and 216 just after the fasteners are deployed with the convergingstylets. As soon as the fasteners 214 and 216 are deployed, the tissuelayers 180 and 182 shift to establish equilibrium. The result may beseen in FIG. 15. The shifting of the tissue layers 180 and 182 hascaused the inner tissue layer to gather at a gathering point 212. Havingbeen secured by the fasteners 214 and 216, the gathered tissue willtighten the LES. At the same time, while the fasteners are deployed, aflap of a GEV restored as previously described is also secured. If thisis repeated for each incremental rotation of the device, the pleatedstructure of gathering points 212 a, 212 b, and 212 c are created andmaintained by fasteners 214 a and 216 a, 214 b and 216 b, and 214 c and216 c, respectively.

In FIGS. 17 through 21, another embodiment is shown wherein the tissue,gathered for tightening the LES, is gathered by vacuum displacement.More specifically, FIG. 17 and the sectional view of FIG. 18 showanother device 300 for restoring a GEV and tightening the LES wherein aflap of stomach tissue for restoring the GEV is formed between thechassis 104 and the bail 106 of the device 300. The chassis 104 includesthe longitudinal channel 210 for receiving the gathered tissue. Here,however, the device further includes vacuum ports 302 that communicatewith the channel 210. The ports 302 communicate with a lumen 304 thatextends from the chassis 104 and through the longitudinal member forcoupling to a vacuum source. The resulting vacuum pull through the ports304 will cause the tissue of the inner tissue layer 180 to be displacedand gathered into the channel 210.

The sectional view of FIG. 19 illustrates the inner tissue layer 180being displaced by the vacuum pull into the channel 210 at a gatheringpoint 212. Also, the fastener deployment stylets 202 and 204 have beenadvanced through the inner tissue layer 180. In this state, theassemblage is now ready for the deployment of fasteners 214 and 216 tomaintain the restored GEV and the tightened LES.

FIGS. 20 and 21 show the fasteners 214 and 216 after deployment. Again,the fasteners are deployed on opposite sides of the gathering point 212.Of course, as previously shown and described with reference to FIG. 11,additional fasteners may also be deployed. Still further, if additionalflap portions are to be formed for restoring the GEV, the device may berotated and the tissue shaping procedure may be repeated. The innertissue layer 180 may receive additional gathering as well if further LEStightening is necessary.

Hence, as may be seen from the foregoing, according to variousembodiments shown and described herein, the present invention providesan assembly and method for restoring a GEV and concurrently therewith,tightening the LES. The GEV restoration and LES tightening may both beperformed transorally in a minimally invasive manner. Since boththerapies are concurrently provided in the same procedure, the patientis spared the inconvenience of and recovery from separate procedures.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is thereto intended inthe appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

Referring now to FIG. 22, with the stomach still inflated to the firstpressure, the endoscope is positioned inside the device just past thehinged connection 1107 of the bail 1106 and chassis 1104. With theendoscope being located just past the hinged connection 1107, the bailis then actuated to an approximally one-half closed position asillustrated. As the bail moves, the bail should be watched to make surethat it moves towards the greater curve 1056 so it can move freely inthe open space of the gastric cavity. With the endoscope in the positionas shown in FIG. 22, the bail should be visible at all times.

Referring now to FIG. 23, the endoscope 1110 is advanced back into thestomach 1043 and brought to a reflexed view as illustrated so that itmay look back on the device 1100. With the operating end of the devicein clear view, the device 1100 is positioned in the center of thegastroesophageal flap valve to be formed where the posterior andanterior groove should be. This position is typically opposite thelesser curve 1045.

Next, the device positioning relative to the Z-line 1052 is checked tomake sure that the marker 1132 is in its desired position relative tothe Z-line 1052. In accordance with this embodiment, the marker 1132 isplaced adjacent or is aligned with the Z-line 1052.

With the device in the correct starting position as shown in FIG. 23, avacuum pump communicating with orifices 1146 is energized to pull avacuum through the orifices 1146. This causes the orifices to engage thewall of the esophagus 1041 for gripping the esophagus. As previouslymentioned, this invagination permits the esophagus to be pushed into thestomach by distal movement of the elongated member 1102 to treat ahiatal hernia and to stabilize the position of the device within thestomach. The vacuum is continued to be pulled through the orifices 1146until the vacuum is above the 50 kps mark on the vacuum pump. The deviceis then pushed gently aborally to reposition the esophagus to correct ahiatal hernia. It may be noted that this maneuver can also be used tovisually check the position of the faster delivery point 1144 relativeto the Z-line. During this maneuver, the esophagus may roll back onitself and expose the esophageal Mucosa and the Z-line adjacent to thefastener delivery ports.

Referring now to FIG. 24, with the device locked in position by thevacuum orifices 1146, the area in which the helical coil is to beengaged may be identified. The gripping location may be largelydetermined by the size or length of the flap to be restored of therestored gastroesophageal flap valve. This of course may differ from onepatient to another depending on the severity of the hiatal hernia andthe degree of valve degradation. Once the gripping location is selected,the stomach 1043 is inflated to a second and higher pressure. Theinflation pressure of the stomach is increased to the second and higherpressure so that the Mucosa appears tight and the folds essentiallyflatten. With the correct gripping spot identified, the bail 1106 ismoved to position the tip of a helical coil 1115 at the correct grippingspot. Next, the device 1100 is gently pulled upwardly or orally untilthe bail contacts the tissue at the desired gripping spot. Next, thehelix 1115 is advanced by the pushing of the cable 1116 until the helixpushes into the Mucosa. Next, the cable 1116 is turned to likewise turnthe helix 1115 in a clockwise direction to screw the helix into thetissue. As the cable is turned, some wind-up may be filled in the helixdrive cable.

With the helical coil 1115 firmly seated in the tissue, the wind-up inthe cable 1116 is released. Referring now to FIG. 25, with the retractorfirmly seated in the tissue, the device 1100 may be advanced slightlyorally while at the same time the bail 1116 may be opened slightly. Thisreleases the cable 1116 from the guide tube which has now been pulledback into the bail 1106. The cable 1116 exits the guide tube 1122 byslipping through the circuitous slit 1126. This operation is moreparticularly described in U.S. patent application Ser. No. 11/061,318,filed Feb. 18, 2005. Also at this time, the correct positioning of thedevice relative to the Z-line may be verified.

With the bail 1106 slightly opened and the helix 1115 engaged with thetissue 1043, the interior of the stomach is now deflated through theendoscope 1110. The stomach should be deflated such that the tissueappears loose and collapsed with the Mucosa folds being prominent.However, enough room should be left to view the device.

Referring now to FIG. 26, the gastric tissue is now gently pulled withthe helix 1115 and cable 1116 towards the hinged connection 1107 and thevalve mold to be formed by the chassis 1104 and closing bail 1106. Oncethe helix is fully retracted into the bail 1116, it is locked in place.The bail 1106 may now be closed and the device and anatomy will appearas shown in FIG. 27. Here it will be noted that the stomach tissueaboral of the Z-line 1052 is confined between the bail 1106 and chassis1104 to create a fold 1150. The fold is also adjacent the fastenerdelivery point 1144 at the end of the fastener guide lumen. Since thefastener deployment point 1144 is a known predetermined distance fromthe marker 1132 of the window 1130, and since the marker 1132 is alignedwith the Z-line 1052, when a fastener is delivered from the fastenerdeployer of the device, the fastener will exit the fastener deliverypoint 1144 at a point known to be aboral of the Z-line 1052. Thisassures that only serosa tissue is being adhered to serosa tissue in thefixation of the stomach tissue in creating the flap 1150. The flap 1150comprises layers 1180 and 1182 of stomach tissue.

With the tissue layers 1180 and 1182 now disposed within the mold of thechassis 1104 and bail 1106, the bail 1106 may now be locked with respectto the chassis 1104. It is now time to fasten the tissue layers 1180 and1182 together by ejecting a fastener from the fastener deployer lumen1142 at the fastener delivery point 1144.

Before a fastener is ejected from the fastener deployer lumen 1142, thestomach is once again inflated through the endoscope 1110. The stomachis inflated to a point where one has a good view of the tissue fold andbail 1106.

FIGS. 29 and 30 illustrate a manner in which the device 1100 of FIGS.3-13 may deploy a fastener 1200 through the layers 1180 and 1182 ofgripped stomach tissue. The fastener 1200 generally includes a firstmember 1202, a second member 1204, and a connecting member 1206. As maybe noted in FIG. 30, the first member 1202 and second member 1204 aresubstantially parallel to each other and substantially perpendicular tothe connecting member 1206 which connects the first member 1202 to thesecond member 1204.

The first member 1202 is generally cylindrical or can any shape. It hasa channel 1212 that extends therethrough. The though channel 1112 isdimensioned to be slidingly received on a tissue piercing deploymentwire 1264.

The first member 1202 includes a pointed tip 1224. The tip 1224 may beconical and more particularly takes the shape of a truncated cone. Thetip can also be shaped to have a cutting edge in order to reduce tissueresistance.

The first member 1202 also has a continuous lengthwise slit 1205. Theslit 1225 includes an optional slot 1226 that communicates with thethrough channel 1212. The slot 1226 has a transverse dimension for morereadily enabling receipt of the tissue piercing deployment wire 1264during deployment of the fastener 1200. Also, because the fastenermember 1202 is formed of flexible material, the slit 1225 may be madelarger through separation to allow the deployment wire to be snappedinto and released from the through channel 1212.

In addition to the fastener 1200 and the deployment wire 1264, theassembly shown in FIGS. 29 and 30 further includes a pusher 1266 and aguide tube 1268. The subassembly of the tissue piercing wire 1264,fastener 1200, and pusher 1266 may be guided to its intended locationrelative to the tissue layers 1180 and 1182 by the guide tube 1268. Thetissue piercing wire 1264, fastener 1200, and the pusher 1266 are allinitially within the guide tube 1268. The guide tube 1268 isrepresentative of the fastener deployment guide and to that end,includes the fastener deployment guide lumen 1142. The subassembly ofthe tissue piercing wire 1264, fastener 1200, and pusher 1266 may beguided to its intended location relative to the tissue layers 1180 and1182 by the guide lumen 1142.

As shown in FIGS. 29 and 30, the tissue piercing wire 1264 has a tip1270 helping it pierce the tissue layers 1180 and 1182 that will formthe restored gastroesophageal flap valve flap 1150. The pusher 1266 haspushed the first member 1202 of the fastener 1200 through the tissuelayers 1180 and 1182 on the tissue piercing wire 1264. This may beaccomplished by moving the wire 1264 and the pusher 1266 together.

As may be further noted in FIG. 29, the first member 1202 is clearingthe wire 1264 and tissue layer 1182. The tissue piercing wire 1264 maynow be retracted into the pusher 1266 and the tissue piercing wire 1264and pusher 1266 may be withdrawn.

FIG. 30 illustrates the fastener 1200 in its fully deployed position. Itwill be noted that the fastener has returned to its original shape. Thetissue layers 1180 and 1182 are fastened together between the firstmember 1202 of the fastener 1200 and the second member 1204 of thefastener 1200. The connecting member 1206 extends through the tissuelayers 1180 and 1182.

In accordance with a further method of utilizing the fastener deploymentassembly of FIGS. 29 and 30, the tissue piercing wire 1264 may be firstadvanced through the tissue layers 1180 and 1182 by a full stroke andthen locked. The tip 1270 of the deployment wire 1264 should extendthrough the bail 1206 with minimal tenting of the tissue. Next, thepusher 1266 is advanced. Visual confirmation that the first fastenermember 1202 is through the tissue is then made. In doing so, the verydistal end of the pusher 1266 may be visible when the first member 1202of the fastener 1200 is fully deployed. Next, while holding the pusher1266 at the last noted position, the tissue piercing wire 1264 isretracted. The first member 1202 of the fastener 1200 will fall to theside when the tissue piercing wire 1264 reaches the pusher 1266. Whenthe tissue piercing wire 1264 reaches the pusher 1266 and after thefastener 1200 is deployed, the pusher 1266 is pulled back with thetissue piercing wire. If additional fastener deployment guides areprovided, the foregoing steps for deploying a fastener such as fastener1200 may be repeated.

With the fasteners successfully deployed, the vacuum pull throughorifices 1146 may now be turned off to release the device from theesophagus wall as illustrated in FIG. 28. At this time, the bail 1106 ofthe device 1100 may be slightly opened and the helical coil 1115 may bereleased from the stomach tissue. As may be seen in FIG. 28, theprocedure just described results in a flap 1150 to be formed. At thistime, an additional fastener or fasteners may be loaded onto the tissuepiercing deployment wire 1264 at the proximal end of the longitudinalmember 1102.

To render the flap uniform about the opening of the orifice into thestomach, it is necessary at this time to rotate the device 1102 andrepeat the previously described procedure for forming a further flapportion. Before this is done, however, it is desirable to position thebail 1106 to an almost closed position. Then, the device 1100 is movedaborally further into the stomach until the tip end 1107 of the bail1106 comes to rest on the tip 1151 of the newly formed flap portion.This is the location where the helical coil 1115 will next engage thestomach tissue for molding and fixating as previously described.

The foregoing is repeated until a complete valve flap is formed. Whenthe appearance of the valve flap is satisfactory as viewed through theendoscope for visual confirmation, the helical coil 1115 is reloadedback into its original position with the device 1100. The vacuum suctionthrough orifices 1146 is turned off to release the wall of the esophagusfrom the device. The bail 1106 is then moved to a fully opened positionas seen, for example, in FIG. 22. The endoscope may now be retractedalong with the stylet and pusher controls. With the retraction of theforegoing verified, the stomach may now be deflated and the device 1100may be removed from the stomach and esophagus. This then completes theprocedure according to this embodiment of the invention.

What is claimed is:
 1. An apparatus for forming a fold of stomachtissue, comprising: a longitudinal member having a distal end arrangedto be received within a stomach; a chassis hingedly coupled to a bail atthe distal end of the longitudinal member to form a mold to shapestomach tissue into a flap of a restored gastroesophageal valve; ahelical coil at a distal end of a cable configured for gathering thestomach tissue at or aboral to the gastroesophageal junction to reducean esophageal opening into the stomach; the cable extends from a guidetube on the bail so that the helical coil can be inserted into stomachtissue and the cable can be retracted into the guide tube and pull thestomach tissue into the mold; a fastener deployer having fastenerdeployment guide tubes for receiving deployment stylets, the deploymentstylets configured to advance through the fastener deployment guidetubes and extend through one layer of the fold of stomach tissue; afastener configured to advance over each stylet and extend through thefold of stomach tissue thereby reducing the esophageal opening.
 2. Theapparatus of claim 1, wherein at least two fasteners are deployed by thefastener deployer.
 3. The apparatus of claim 1, wherein the bail has anopen position and a closed position so that as the bail closes towardthe chassis the bail folds the stomach tissue such that serosa tissuecontacts serosa tissue to form the gastroesophageal valve from stomachtissue layers.
 4. An apparatus for treating a stomach disorder involvinga patient's stomach, esophagus, and esophageal opening into the stomach,comprising; a chassis hingedly coupled to a bail at a distal end of alongitudinal member to form a mold to shape stomach tissue into a flapof a restored gastroesophageal valve; a tissue gatherer that isconfigured to fold stomach tissue at or aboral of the gastroesophagealjunction to reduce the esophageal opening; a fastener deployer havingfastener deployment guide tubes for receiving deployment stylets, thedeployment stylets configured to advance through the fastener deploymentguide tubes and extend through one layer of the fold of stomach tissue;and a fastener configured to advance over each stylet and extend throughthe fold of stomach tissue thereby forming the gastroesophageal valve.5. The apparatus of claim 4, wherein the tissue gatherer is arranged todisplace the stomach tissue into the esophageal opening.
 6. Theapparatus of claim 5, wherein the tissue gatherer comprises a helicalcoil for insertion into the stomach tissue.
 7. The apparatus of claim 4,wherein the tissue gatherer comprises a helical coil at a distal end ofa cable to configured for gathering stomach tissue, the cable extendsfrom a guide tube on the bail so that a helical coil can be insertedinto stomach tissue and the cable can be retracted into the guide tubeand pull the stomach tissue into the mold.